Acellular dermal matrix sheet allografts having specialized mesh patterns

Abstract

There is disclosed a packaged allograft implant configured for implantation in a human recipient. In an embodiment, the packaged allograft implant includes an acellular dermal matrix sheet having a top surface and a bottom surface in opposition to one another, a perimeter surrounding the top surface and the bottom surface, and a thickness extending between the top surface and the bottom surface. The packaged allograft implant further includes a mesh pattern extending across at least a portion of the top surface and the bottom surface of the acellular dermal matrix sheet, the mesh pattern providing through-holes extending between the top surface and the bottom surface of the acellular dermal matrix sheet, and the mesh pattern having a plurality of mesh lines extending in a first direction and a second direction. The first direction and the second direction are orthogonal to one another so as to allow a given amount of stretch in each of the first direction and the second direction. Other embodiments are also disclosed.

What is claimed is: 
     
         1 . A packaged allograft implant configured for implantation in a human recipient, the packaged allograft implant comprising:
 an acellular dermal matrix sheet having a top surface and a bottom surface in opposition to one another, a perimeter surrounding the top surface and the bottom surface, and a thickness extending between the top surface and the bottom surface; and   a mesh pattern extending across at least a portion of the top surface and the bottom surface of the acellular dermal matrix sheet, the mesh pattern providing through-holes extending between the top surface and the bottom surface of the acellular dermal matrix sheet, and the mesh pattern having a plurality of mesh lines extending in a first direction and a second direction, wherein the first direction and the second direction are orthogonal to one another so as to allow a given amount of stretch in each of the first direction and the second direction.   
     
     
         2 . The packaged allograft implant of  claim 1 , wherein the mesh lines have a length of 1.0 mm to 3.48 mm. 
     
     
         3 . The packaged allograft implant of  claim 1 , wherein the mesh lines have a length of up to 4 mm. 
     
     
         4 . The packaged allograft implant of  claim 1 , wherein the mesh lines have a spacing apart from one another of 1.0 mm to 1.5 mm. 
     
     
         5 . The packaged allograft implant of  claim 1 , wherein the mesh lines have a spacing apart from one another of up to 4 mm. 
     
     
         6 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is an alternating pattern of vertical and horizontal mesh lines. 
     
     
         7 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a cross pattern of intersecting mesh lines. 
     
     
         8 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a diamond pattern of mirrored 45-degree angle oriented mesh lines. 
     
     
         9 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a multiple quadrant pattern, with parallel mesh lines in opposing quadrants and perpendicular mesh lines in neighboring quadrants, and the multiple quadrant pattern contained in a circular shaped perimeter with the mesh lines. 
     
     
         10 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a row pattern formed by column of horizontal mesh lines followed by a column of vertical mesh lines, with the lines alternating for each column, with the mesh lines disposed on an acellular dermal matrix sheet forming an allograft for implantation in a human recipient. 
     
     
         11 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a circular pattern with arcuate mesh lines positioned about a pole location adjacent the center of the circular pattern, and the pattern contained in a circular shaped perimeter, with the mesh lines disposed on an acellular dermal matrix sheet forming an allograft for implantation in a human recipient. 
     
     
         12 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is an alternating semi-circle mesh pattern with arcuate mesh lines positioned in an alternating configuration with one another, with the mesh lines disposed on an acellular dermal matrix sheet forming an allograft for implantation in a human recipient. 
     
     
         13 . The packaged allograft implant of  claim 1 , wherein the mesh pattern is a spiral pattern with mesh lines emanating from a central point in a spiral from a center of the mesh pattern, and the pattern contained in a circular shaped perimeter, with the mesh lines disposed on an acellular dermal matrix sheet forming an allograft for implantation in a human recipient. 
     
     
         14 . A method of manufacturing an acellular dermal matrix (ADM) graft product for use in a reconstructive surgical procedure, the method comprising:
 providing a portion of donor-derived skin, the portion of the donor-derived skin having a full thickness;   removing an epidermis layer and a fat layer from the portion of the donor-derived skin to form a portion of dermal tissue;   decellularizing the portion of the dermal tissue to form a portion of ADM graft material;   forming a mesh patterned ADM graft material by imparting a plurality of mesh lines in a mesh pattern on the portion of ADM graft material, the mesh pattern having the plurality of mesh lines extending in a first direction and a second direction, wherein the first direction and the second direction are orthogonal to one another so as to allow a given amount of stretch in each of the first direction and the second direction;   verifying that a thickness of the pre-defined shape equals a specified thickness;   packaging the mesh patterned ADM graft with sterile water to form a packaged mesh pattern ADM graft within the sterile water at room temperature; and   irradiating the packaged mesh patterned ADM graft to a sterility assurance level of a desired level to form the ADM graft product.   
     
     
         15 . The method of  claim 14 , wherein the step of packaging the mesh patterned ADM graft includes packaging in a medical sterilization pouch to form the packaged mesh patterned ADM graft product. 
     
     
         16 . The method of  claim 14 , wherein the step of irradiating the packaged ADM graft product to the sterility assurance level includes irradiating to at least the desired level of 10 −6 . 
     
     
         17 . An acellular dermal matrix (ADM) graft stored as a packaged ADM graft product prepared by a process comprising the steps of:
 providing a portion of ADM tissue having a thickness between  1  mm and  2  mm;   imparting a plurality of mesh lines in a mesh pattern on the portion of ADM graft material to form a mesh patterned ADM graft, the mesh pattern having the plurality of mesh lines extending in a first direction and a second direction, wherein the first direction and the second direction are orthogonal to one another so as to allow a given amount of stretch in each of the first direction and the second direction;   verifying the thickness of the mesh patterned ADM graft;   packaging the mesh patterned ADM graft with sterile water to form a packaged mesh patterned ADM graft within the sterile water at room temperature; and   irradiating the packaged mesh patterned ADM graft to a sterility assurance level of a desired level to form the packaged mesh patterned ADM graft product.   
     
     
         18 . The ADM graft stored as the packaged graft product prepared by the process of  claim 17 , wherein the step of packaging the mesh patterned ADM graft includes packaging in a medical sterilization pouch to form the packaged mesh patterned ADM graft. 
     
     
         19 . The ADM graft stored as the packaged graft product prepared by the process of  claim 17 , wherein the step of irradiating the packaged mesh patterned ADM graft to the sterility assurance level includes irradiating to at least the desired level of 10 −6 .